Disposable Grasping Forceps
FDA 510(k) K822491 · Van-Tec, Inc.
510(k) numberK822491
Submission
- Device name
- Disposable Grasping Forceps
- Applicant
- Van-Tec, Inc.
Mchenry, IL, US - Received
- August 18, 1982
- Decision date
- September 17, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEN – Forceps, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031828 | Naturalase LP Nd:Yag LaserGEN · Traditional | Focus Medical, LLC | 07/17/2003SE |
| K953962 | ForcepsGEN · Traditional | Biopsys Medical, Inc. | 09/08/1995SE |
| K932385 | Suture Removing ForcepsGEN · Traditional | Rocket of London, Ltd. | 08/06/1993SE |
| K904723 | ForcepsGEN · Traditional | Minto Research & Development, Inc. | 07/26/1991SE |
| K911159 | Palpation ProbeGEN · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K900960 | GS-1500 Claw Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900952 | GS-1200 Grasping/Extracting Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900951 | GS-7000 Clip-Applying Forcep, 10MM, Medium ClipGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900948 | GS-1002 Grasping Forcep, 5MM with RatchetGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K891896 | Tissue Forceps, Various TypesGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
More from Zinnanti Surgical Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880099 | Van-Tec Bladder EvacuatorKQT · Traditional | 03/02/1988SE |
| K880098 | Van-Tec Auto Biopsy NeedleKNW · Traditional | 03/02/1988SE |
| K880096 | Van-Tec Aspiration Biopsy System W/Collection CupKNW · Traditional | 03/02/1988SE |
| K880095 | Berger Prostate Culture Cytology BrushFDX · Traditional | 03/02/1988SE |
| K880094 | Van-Tec Endopyelotomy KnifeEMF · Traditional | 02/29/1988SE |
| K874112 | Van-Tec Double Occlusion Balloon CatheterKOD · Traditional | 02/11/1988SE |
| K871779 | Helical Stone Basket (Disposable)FFL · Traditional | 06/17/1987SE |
| K871777 | Van-Tec Reusable Helical Stone BasketFFL · Traditional | 06/17/1987SE |
| K870696 | Van-Tec Segura Stone Basket W/Protective SheathFFL · Traditional | 03/30/1987SE |
| K870679 | Van-Tec Modular Flexible CystourethroscopeFBO · Traditional | 03/30/1987SE |
Questions and answers
When was Disposable Grasping Forceps cleared by the FDA?
Disposable Grasping Forceps (K822491) received a 510(k) decision of Substantially Equivalent on September 17, 1982, 30 days after the submission was received.
What is the product code of K822491?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.